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A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC

NCT06699121 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-10-24

No results posted yet for this study

Summary

The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Interventions

DRUG

LB-P8 low-dose

One capsule QD (1×10\^10 CFU/day) oral administration

DRUG

LB-P8 high-dose

One capsule QD (1×10\^11 CFU/day) oral administration

DRUG

Placebo

One capsule QD oral administration

Sponsors & Collaborators

  • LISCure Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2028-03-31
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699121 on ClinicalTrials.gov